MAUDE Adverse Event Report: K2M, INC. REDUCTION JACK; CRICKET 2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	6201-90084
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of investigation.
Event or Problem Description
This report summarizes one malfunction event where the 'foot" of a mesa deformity reduction jack cricket broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Upon inspection and analysis of the returned device, the reported event of tip fracture could not be confirmed.It was observed that the proximal pin of the distal leg had sheared, resulting in the leg of the cricket disengaging from the medial housing.This event is not reportable as no death or serious injury in state of health of a patient, user, or other person has occurred or is likely to occur.
Event or Problem Description
This report summarizes one malfunction event where the 'foot" of a mesa deformity reduction jack cricket broke intra-operatively.Surgery was successfully completed with no delay.No adverse consequences or medical intervention were reported.

• Brand Name: REDUCTION JACK; CRICKET 2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11745675
• Report Number: 3004774118-2021-00126
• Device Sequence Number: 14417079
• Product Code: LXH
• UDI-Device Identifier: 10888857320468
• UDI-Public: 10888857320468
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6201-90084
• Device Lot Number: KEAH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 07/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1